Director Mammalian Operations

Job title:

Director Mammalian Operations

Company:

AGC Biologics

Job description

Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe, creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients’ lives by bringing new biopharmaceuticals to market.Would you like to be a part of AGC Biologics growing success?At AGC Biologics A/S we work with development and GMP manufacturing of APIs for both commercial products and products in all clinical phases. We are a client centric CDMO, and the partnership with our clients, working side by side with the clients, is our focus.Within Manufacturing we are looking for an experienced Director to lead one of our Mammalian Operations Departments. AGC Biologics is in a period of rapid growth and the Director will play an important role in ensuring the organizational development for the journey ahead.The department
The new Director will report to the Sr. Director of Mammalian Manufacturing with a total of 175 employees. The new director will head up a department consisting of approx. 40 employees organized in; Upstream operations, Buffer and Downstream operations. The teams are each headed up by a team leader reporting to the Director.Mammalian Manufacturing is responsible for the production of Drug Substance for pre-clinical, clinical, and commercial use. The Upstream team prepares medias and run seed trains, fed batch- and perfusion production processes and harvest operations. The downstream team runs a variety of purification steps, such as chromatography, virus inactivation, filtrations, virus filtration, UF/DF etc. The production platform is based on Single-Use disposable technologies.The department is responsible for production activities on one production line and ramp-up of another in our new state of the art manufacturing facility.The position

• Leading leaders by providing leadership, guidance, and performance feedback.
• Ensure operational execution of products in GMP compliance at all times.
• Talent management – Manage and develop leaders and teams.
• Digital transformation.
• Ways of Working – Continuous operational improvements with yearly Manufacturing Improvement plan, Steering committees on projects, customer dialog.
• Manufacturing capacity planning and workforce planning.
• Sponsor and driver of site initiatives and continuous improvements.
• Align efforts with PD/MSAT, QA and MPS.
• Role model for AGC values.
• Manage performance and development of direct reports to ensure achievement of organizational and department goals and a productive environment.
• Provide leadership and take a leading role during FDA and EMA Inspection’s and during customer audits.
• The Director will work closely with the members of the manufacturing Leadership Team and other stakeholders in the organization.
• Management appointed EHS responsible.

Critical KPI’s/Measured on:

• Team retention and well-being rate.
• Deviation rate.
• Batch release time.
• Batch success rate.
• Correction rate.

Your profile

• Experience in leading leaders.
• 10+ years of relevant experience in the biopharmaceutical industry.
• Academic degree (preferably in Life Science).
• Sound knowledge of cGMP and firsthand experience with operations under cGMP.
• Demonstrated knowledge within execution of Manufacturing operations.
• Ability to communicate clearly and professionally in written and spoken English.
• Demonstrated experience in driving continuous improvement and/or productivity programs.
• Exceptional leadership qualities, with the strong management skills necessary to oversee and grow a first class, results oriented Manufacturing Department.
• Highly-motivated with strong sense of urgency, positive can do attitude and not afraid of rolling up the sleeves, in the process of maturing the organization.

How to apply
Send your application as soon as possible and not later than January 26, 2024. We process the applications as we receive them and qualified applicants can expect to be interviewed before the deadline.If you need further information about the position, please feel free to contact Per Hommelgaard (Sr. Director Mammalian Manufacuring) at +45 2760 2179.At AGC Biologics, we focus on your talent and potential, which is not limited by your previous experience. We look for those that lead with purpose, passion, and individuality, and serve as a partner to help you identify, develop, and achieve your career goals.Our culture at AGC Biologics is defined by the six core values: Knowledge, Trust, Quality, Ingenuity, Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. Want to keep posted about our growth and learn more about our company? Follow us on and give us a quick Like on !AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinances.

Expected salary

Location

København

Job date

Sat, 04 Jan 2025 06:52:48 GMT

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